Project Manager

QRC Group; Aibonito (PR); In loco; USD 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

QRC Group in Aibonito, Puerto Rico is seeking an experienced Project Manager to lead and manage projects in aseptic areas, especially in development, validation, and FDA submission processes for pharmaceutical and medical device products.

You will develop timelines, budgets, and resource plans, coordinate all stages from design to FDA submission, and ensure cross-functional alignment with R&D, QA, and regulatory affairs to deliver compliant, on-time results.

Competenze

• 8+ years of project management experience in a regulated pharmaceutical, biotechnology, or medical device industry.
• Experience leading projects through FDA submissions and knowledge of CFR Part 210/211, 21 CFR Part 820.
• Experience with aseptic processing, validation protocols, GMP, and equipment qualification.
• Experience with process and cleaning validation in aseptic manufacturing.

Mansioni

• Develop project timelines, resource allocation plans, and budgets.
• Coordinate and oversee all stages from design through FDA submission.
• Lead and manage complex aseptic projects in pharma or medical devices.
• Ensure compliance with FDA and other regulatory bodies' requirements.
• Prepare and review FDA submission documentation and regulatory filings.
• Collaborate with R&D, QA, operations, and regulatory affairs for cross-functional alignment.
• Manage risk assessments and mitigation strategies.
• Conduct periodic project reviews and provide status reports to leadership.

Conoscenze

Project management

Regulatory affairs

FDA submissions

Cross-functional leadership

Risk management

Communication skills

Formazione

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Descrizione del lavoro

Aibonito, Puerto Rico | Posted on 11/02/2026

Project Manager to lead and manage projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.

Responsibilities:

• Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.
  
• Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
  
• Lead and manage complex projects related to the development, commissioning, process development and validation of aseptic pharmaceutical or medical device products.
  
• Ensure compliance with FDA and other regulatory bodies’ requirements, particularly in aseptic areas and sterile manufacturing processes.
  
• Prepare and review documentation for FDA submissions and other regulatory filings.
  
• Work closely with internal stakeholders (R&D, quality assurance, operations, regulatory affairs, etc.) to ensure cross-functional alignment and timely execution of project milestones.
  
• Manage risk assessments and mitigation strategies to address project challenges.
  
• Conduct periodic project reviews and provide status reports to senior management, highlighting key project milestones, risks, and issues.
  

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
  
• 8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry, with a focus on aseptic areas and FDA submissions.
  
• Proven track record of leading projects through FDA submissions.
  
• Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).
  
• Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing.